MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM 03.511.246

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-28 for MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM 03.511.246 manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[131714318] Additional product codes: erl and hbe. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[131714319] Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, during the inter-molar distraction osteogenesis (imdo) procedure, two (2) trumatch mandible guide were heating up during pre-drilling. The cylinder and guides were heating up due to the drill. It was noted three (3) drill bits were touching the cylinder because of the angulation of the guide. There was no surgical delay. There was no adverse consequence to the patient and there was no issue with the plates or screws. Concomitant devices reported: mandible plate (part/lot unknown, quantity unknown), mandible screw (part/lot unknown, quantity unknown). This report is for a drill bit. This is report 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2018-59298
MDR Report Key8202882
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-12-28
Date of Report2018-12-05
Date of Event2018-03-02
Date Mfgr Received2018-12-05
Date Added to Maude2018-12-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1SYNTHES SELZACH
Manufacturer StreetBOHACKERWEG 5
Manufacturer CitySELZACH 2545
Manufacturer CountrySZ
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM
Generic NameDRILL, BONE, POWERED
Product CodeDZI
Date Received2018-12-28
Catalog Number03.511.246
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-28

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